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Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

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Trial Profile

Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy2 Trial)

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 20 May 2024

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At a glance

  • Drugs Rinvecalinase alfa (Primary) ; Rinvecalinase alfa (Primary)
  • Indications Stroke
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ReMEDy2
  • Sponsors DiaMedica Therapeutics
  • Most Recent Events

    • 08 May 2024 According to a DiaMedica Therapeutics media release,the Australian Stroke Trials Network has completed its endorsement of DiaMedica's protocol and DiaMedica is currently selecting study sites. The Company plans to work with many of the same highly-engaged centers it worked with in the ReMEDy1 trial. Australian site activation remains on track to commence before the end of 2024.
    • 08 May 2024 According to a DiaMedica Therapeutics media release, with the support of the Canadian Stroke Consortium, the required Senior Medical Officer, who will serve as the national physician investigator for Canada, has been engaged and six quality sites have been identified for inclusion in the trial. DiaMedica currently expects to submit its regulatory filings to Health Canada this month and expects a response by the end of June.
    • 08 May 2024 According to DiaMedica Therapeutics media release the first clinical sites for this trial were opened in December 2023 and as of the date of this press release, eight sites have now been opened.
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